Drug shortages on the rise

HEALTH CARE

Rob Stein, Washington Post

Published 4:00 am, Sunday, May 1, 2011

Doctors, hospitals and federal regulators are struggling to cope with an unprecedented surge in drug shortages in the United States that is endangering cancer patients, heart attack victims, accident survivors and a host of other ill people.

A record 211 medications became scarce in 2010 - triple the number in 2006 - and at least 89 new shortages have been recorded through the end of March, putting the nation on track for far more scarcities.

The paucities are forcing some medical centers to ration drugs - including one urgently needed by leukemia patients - postpone surgeries and other care, and scramble for substitutes, often resorting to alternatives that may be less effective, have more side effects and boost the risk for overdoses and other sometimes-fatal errors.

The causes vary from drug to drug, but experts cite a confluence of factors: Consolidation in the pharmaceutical industry has left only a few manufacturers for many older, less-profitable products, meaning that when raw material runs short, equipment breaks down or government regulators crack down, the snags can quickly spiral into shortages.

No one is systematically tracking the toll of the shortages, but reports are emerging of delayed treatments, anxious searches for desperately needed drugs, devastating injuries from mistakes and less-adequate drugs, and even possible deaths.

Federal regulators have been rushing to alleviate the shortages, sometimes helping firms resume production more quickly or approving emergency imports of supplies from overseas. The Food and Drug Administration eased a shortage of the anesthetic propofol last year by allowing foreign importation, for example, and this year approved bringing in several other medications, including two cancer drugs.

"The types of products we're seeing shortages of are really concerning," said Valerie Jensen, who heads the FDA's Drug Shortages Program. "This is affecting oncology drugs, critical care drugs, emergency medicine drugs. We're doing everything we can under our current authority to try to deal with this situation."

Many of the shortages involve older, cheaper generic medications that are less profitable, causing many firms to stop producing them and leaving fewer sources. Most involve "sterile injectable" medications that are more complicated to produce and therefore are more prone to manufacturing problems. In addition, drug companies increasingly rely on raw materials from other countries.

Whatever the causes, many of the affected drugs are mainstays of medical care, such as the potent painkiller morphine, norepinephrine, which is commonly used in emergency rooms, and electrolytes, which are often given to patients in intensive care.

But shortages have been reported in many categories of drugs, including antibiotics, and drugs central to the treatment of many cancers, forcing oncologists to delay or alter carefully timed chemotherapy regimens.

The drug cytarabine has caused the most concern and gotten the most attention, because it is highly effective for treating several forms of leukemia and lymphoma but must be administered as quickly as possible, especially to patients with acute myeloid leukemia.